Metformin EP Impurity E (Hydrochloride Salt), PurCert
PurCert
Properties
| Water Solubility | Slightly soluble |
| Assay Purity | >=98% |
| M pt. | 148 - 151 °C |
| Form | Solid |
Safety Information
| Hazard Statement(s) | H302 |
| Precautionary Statement | P264 - P270 - P301 + P312 - P501 |
| GHS Pictogram |
|
| Signal word | Warning |
| HS Code | 29252990 |
| Storage Temp. | 2-8 °C |
| Storage Class | 11 - Combustible Solids |
| UN Number | NA |
Description
Application
Metformin EP Impurity E is used as a pharmaceutical reference standard for the identification quantification and quality control of impurities in Metformin active pharmaceutical ingredients (APIs) and finished dosage forms in accordance with European Pharmacopoeia (EP) specifications.
Purpose
The purpose of Metformin EP Impurity E is to support pharmaceutical quality assurance by enabling accurate impurity profiling analytical method validation stability studies and regulatory compliance during the manufacture of Metformin.
General Description
Metformin EP Impurity E is a specified organic impurity described in the European Pharmacopoeia that is used as a certified analytical reference material for impurity testing and quality control and it is not intended for therapeutic or clinical use.
Documents
| SDS | |
| COA | |
| Specification | |
| Bulk quote order form | |
| Sample COA |
